Файл: part01.pdf

Page 2​

PS3.1: DICOM PS3.1 2020a - Introduction and Overview​

Copyright © 2020 NEMA​

A DICOM® publication​

- Standard -​

DICOM PS3.1 2020a - Introduction and Overview​ Page 3​

Table of Contents​

- Standard -​

- Standard -​

- Standard -​

- Standard -​

Notice and Disclaimer​

The information in this publication was considered technically sound by the consensus of persons engaged in the development and​ approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement​ among every person participating in the development of this document.​

NEMA standards and guideline publications, of which the document contained herein is one, are developed through a voluntary​ consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have​ an interest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness​ in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy​ or completeness of any information or the soundness of any judgments contained in its standards and guideline publications.​

NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect,​ consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document.​ NEMA disclaims and makes no guaranty or warranty, expressed or implied, as to the accuracy or completeness of any information​ published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular purposes​ or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or seller's products or services by​ virtue of this standard or guide.​

In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf​ of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using​ this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional​ in determining the exercise of reasonable care in any given circumstances. Information and other standards on the topic covered by​ thispublicationmaybeavailablefromothersources,whichtheusermaywishtoconsultforadditionalviewsorinformationnotcovered​ by this publication.​

NEMA has no power, nor does it undertake to police or enforce compliance with the contents of this document. NEMA does not cer-​ tify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance​ with any health or safety-related information in this document shall not be attributable to NEMA and is solely the responsibility of the​ certifier or maker of the statement.​

- Standard -​

- Standard -​

Foreword​

The DICOM Standards Committee is an independent, international standards development organization comprising biomedical pro-​ fessional societies whose specialties include the use of medical imaging, manufacturers of medical imaging equipment and related​ information systems, and government agencies, trade associations, and other standards development organizations with an interest​ in standardization of medical imaging information and related data. Membership is open to all organizations with a material interest​ in the work of the Committee. The Committee collaborates closely with other standards development organizations in the fields of​ Healthcare Informatics and Electrical Equipment in Medical Practice. The Secretariat of the Committee is the National Electrical​ Manufacturers Association and its Medical Imaging and Technology Alliance division.​

The principal product of the Committee is this Standard, Digital Imaging and Communications in Medicine (DICOM).​

This DICOM Standard was developed according to the procedures of the DICOM Standards Committee.​

The DICOM Standard is structured as a multi-part document using the guidelines established in [ISO/IEC Directives, Part 2].​

The Standard is published as NEMA Standard PS3, and its Parts are identified by the numbering of the NEMA publication (PS3.1,​ PS3.2, etc.).​

DICOM® is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to di-​ gital communications of medical information, all rights reserved.​

HL7® and CDA® are the registered trademarks of Health Level Seven International, all rights reserved.​

SNOMED®, SNOMED Clinical Terms®, SNOMED CT® are the registered trademarks of the International Health Terminology​ Standards Development Organisation (IHTSDO), all rights reserved.​

LOINC® is the registered trademark of Regenstrief Institute, Inc, all rights reserved.​

- Standard -​

- Standard -​

1 Scope and Field of Application​

PS3.1providesanoverviewoftheentireDigitalImagingandCommunicationsinMedicine(DICOM)Standard.Itdescribesthehistory,​ scope, goals, and structure of the Standard. In particular, it contains a brief description of the contents of each Part of the Standard.​

1.1 Scope of DICOM​

DigitalImagingandCommunicationsinMedicine(DICOM)isthestandardforthecommunicationandmanagementofmedicalimaging​ information and related data.​

The DICOM Standard facilitates interoperability of medical imaging equipment by specifying:​

•​For network communications, a set of protocols to be followed by devices claiming conformance to the Standard.​

•​The syntax and semantics of Commands and associated information that can be exchanged using these protocols.​

•​For media communication, a set of media storage services to be followed by devices claiming conformance to the Standard, as​ wellasaFileFormatandamedicaldirectorystructuretofacilitateaccesstotheimagesandrelatedinformationstoredoninterchange​ media.​

•​Information that must be supplied with an implementation for which conformance to the Standard is claimed.​

The DICOM Standard does not specify:​

•​The implementation details of any features of the Standard on a device claiming conformance.​

•​Theoverallsetoffeaturesandfunctionstobeexpectedfromasystemimplementedbyintegratingagroupofdeviceseachclaiming​ DICOM conformance.​

•​A testing/validation procedure to assess an implementation's conformance to the Standard.​

1.2 Field of Application​

The DICOM Standard pertains to the field of Medical Informatics. Within that field, it addresses the exchange of digital information​ between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and​ information systems, the scope of this Standard needs to overlap with other areas of medical informatics. However, the DICOM​ Standard does not address the breadth of this field.​

This Standard has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology,​ dentistry,ophthalmologyandrelateddisciplines,andimage-basedtherapiessuchasinterventionalradiology,radiotherapyandsurgery.​ However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary,​ and other medical environments.​

This Standard facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself,​ guarantee interoperability.​

1.3 History​

With the introduction of computed tomography (CT) followed by other digital diagnostic imaging modalities in the 1970's, and the in-​ creasinguseofcomputersinclinicalapplications,theAmericanCollegeofRadiology(ACR)andtheNationalElectricalManufacturers​ Association(NEMA)recognizedtheemergingneedforastandardmethodfortransferringimagesandassociatedinformationbetween​ devices manufactured by various vendors. These devices produce a variety of digital image formats.​

The American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) formed a joint committee​ in 1983 to develop a standard to:​

•​Promote communication of digital image information, regardless of device manufacturer​

•​Facilitate the development and expansion of picture archiving and communication systems (PACS) that can also interface with​ other systems of hospital information​

- Standard -​

•​Allow the creation of diagnostic information data bases that can be interrogated by a wide variety of devices distributed geograph-​ ically.​

ACR-NEMA Standards Publication No. 300-1985, published in 1985 was designated version 1.0. The Standard was followed by two​ revisions: No. 1, dated October 1986 and No. 2, dated January 1988. These Standards Publications specified a hardware interface,​ a minimum set of software commands, and a consistent set of data formats.​

ACR-NEMAStandardsPublicationNo.300-1988,publishedin1988wasdesignatedversion2.0.Itincludedversion1.0,thepublished​ revisions, and additional revisions. It also included new material to provide command support for display devices, to introduce a new​ hierarchy scheme to identify an image, and to add data elements for increased specificity when describing an image.​

In 1993, ACR-NEMA Standard 300 was substantially revised and replaced by this Standard, designated Digital Imaging and Commu-​ nications in Medicine (DICOM). It embodies a number of major enhancements to previous versions of the ACR-NEMA Standard:​

•​It is applicable to a networked environment. The ACR-NEMA Standard was applicable in a point-to-point environment only; for op-​ eration in a networked environment a Network Interface Unit (NIU) was required. DICOM supports operation in a networked envir-​ onment using the industry standard networking protocol TCP/IP.​

•​It is applicable to off-line media exchange. The ACR-NEMA Standard did not specify a file format or choice of physical media or​ logical filesystem. DICOM supports operation in an off-line media environment using industry standard media such as CD-R, DVD-​ R and USB and common file systems.​

•​Itisaserviceorientedprotocol,specifyingthesemanticsofcommandsandassociateddata,andhowdevicesclaimingconformance​ to the Standard react to commands and data being exchanged. Specified services include support for management of the workflow​ of an imaging department. The ACR-NEMA Standard was confined to the transfer of data with only implicit service requirements.​

•​Itspecifieslevelsofconformance.TheACR-NEMAStandardspecifiedaminimumlevelofconformance.DICOMexplicitlydescribes​ how an implementor must structure a Conformance Statement to select specific options.​

In 1995, with the addition of DICOM capabilities for cardiology imaging supported by the American College of Cardiology, the ACR-​ NEMA Joint Committee was reorganized as the DICOM Standards Committee, a broad collaboration of stakeholders across all​ medical imaging specialties.​

1.4 Principles​

1.4.1 Global Applicability and Localization​

DICOM is a world-wide standard that can be used in every locale. It provides mechanisms to handle data that support cultural require-​ ments, such as different writing systems, character sets, languages, and structures for addresses and person names. It supports the​ variety of workflows, processes and policies used for biomedical imaging in different geographic regions, medical specialties and​ local practices.​

Localization to meet the requirements of national or local health and workflow policies can be done without deviating from the​ Standard.Suchlocalizationmayincludespecifyingcodesets(e.g.,procedurecodes),orprofilingdataelementusage(bothspecifying​ locally allowed values, and making elements that are optional in the Standard mandatory for local use).​

Localization and profiling can be specified in a number of mechanisms outside the purview of the DICOM Standard. One such​ mechanismisIntegrationProfilesfromtheIntegratingtheHealthcareEnterprise(IHE)organization.ItisimportantthatProfilingadhere​ to the concept of non-contradiction. A Profile can add requirements but should not contradict DICOM requirements, as that would​ make it impossible to comply with both DICOM and the Profile.​

1.4.2 Continuous Maintenance​

The DICOM Standard is an evolving standard and it is maintained in accordance with the Procedures of the DICOM Standards​ Committee. Proposals for enhancements are welcome from all users of the Standard, and may be submitted to the Secretariat.​ Supplements and corrections to the Standard are balloted and approved several times a year. When approved as Final Text, each​ changebecomesofficial,ispublishedseparately,andgoesintoeffectimmediately.Atintervals,alloftheapprovedFinalTextchanges​ are consolidated and published in an updated edition of the Standard. Once changes are consolidated into an updated edition of the​ Standard, the individual change documents are not maintained; readers are directed to use the consolidated edition of the Standard.​

A requirement in updating the Standard is to maintain effective compatibility with previous editions.​

- Standard -​